Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.
For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.
详细描述
Can be provided on request as the registry rules are no in Dutch
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients indicated for chronic home NIV
排除标准
- •not able to read the written information and/or sign the informed consent form
- •no possibility to perfrom measurements at home
结局指标
主要结局
Sleep quality
时间窗: 6 months
Sleep quality assessing sleep depth and sleep stages
Patient comfort
时间窗: 6 months
Patient comfort assessed by VAS scale
AECOPD
时间窗: 4 months
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Gas exchange
时间窗: 6 months
Transcutaneous monitoring of gas exchange
Hospitalisations for AECOPD
时间窗: 6 months
Hospitalisations for acute exacerbations of COPD
Gas exchange
时间窗: baseline
Transcutaneous monitoring of gas exchange
Gas exchange
时间窗: 2 months
Transcutaneous monitoring of gas exchange
Gas exchange
时间窗: 4 months
Transcutaneous monitoring of gas exchange
Patient comfort
时间窗: baseline
Patient comfort assessed by VAS scale
Patient comfort
时间窗: 2 months
Patient comfort assessed by VAS scale
Patient comfort
时间窗: 4 months
Patient comfort assessed by VAS scale
AECOPD
时间窗: 2 months, 4 months, 6 months
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
AECOPD
时间窗: 2 months
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Sleep quality
时间窗: 2 months
Sleep quality assessing sleep depth and sleep stages
Sleep quality
时间窗: 4 months
Sleep quality assessing sleep depth and sleep stages
次要结局
未报告次要终点